TWM537881U - Surgical implant structure - Google Patents

Description

Surgical implant structure

The present invention is an implant structure, especially a surgical implant structure that is manufactured using high power pulsed magnetron sputtering technology and has high biocompatibility.

Polyetheretherketone (PEEK) is quite suitable as a material for medical implants due to its low modulus of elasticity, high tensile strength, high fatigue strength, and high mechanical durability. However, the biocompatibility of such materials is not good, so how to make an outer coating with high biocompatibility is a very important topic in the technical field.

The High Power Impulse Magnetron Sputtering (HIPIMS) technology was first proposed by Vladimir Kousnetzov et al. in U.S. Patent No. 6,296,472. Then, in 2009, Glen West et al. used Direct Current Magnetron Sputtering (DCMS), Pulsed Direct Current Sputtering (Pulsed DC) and HIPIMS to compare these technologies to polymer bases at the same average power. The material is affected by heat. The results show that HIPIMS has less thermal impact on the substrate and can achieve better film quality. In 2011, Kusiak-Nejman et al. used HIPIMS to prepare copper film on polyester fiber cloth, and investigated the passivation of Escherichia coli on the prepared antibacterial film with different peak currents at a fixed film thickness. In 2012, Oualid Baghriche and other scholars compared the antibacterial research of HIPIMS and DCMS silver-plated film on E. coli on polyester fiber cloth. The results show that the film prepared by HIPIMS has higher antibacterial activity. In the same year, Peter Kelly and other scholars used Pulsed DC and HIPIMS to apply titanium oxide on polymer substrates under the same conditions. The results show that the polymer substrate plated with Pulsed DC is melted and deformed, and the HIPIMS plater is not only undeformed, but even obtains a better crystalline coating.

It can be clearly seen from the above description that HIPIMS technology has attracted considerable attention in the past ten years since its inception due to its excellent characteristics. However, when PEEK is used in medical implants, how to improve the biocompatibility of the implant as a whole to avoid adverse reactions to the human body is the subject of research and research by researchers in the field.

Therefore, how to solve the above problems and lack of use, that is, the creators of the creation and the relevant manufacturers engaged in this industry are eager to study the direction of improvement.

Therefore, in view of the above-mentioned shortcomings, the creators of this creation have collected relevant information, and have designed and developed such new patents through continuous evaluation and modification through multi-party evaluation and consideration, and through years of experience in the industry.

The purpose of this creation is to provide a surgical implant structure that is manufactured using high power pulsed magnetron sputtering techniques and that is highly biocompatible.

In order to achieve the above or other objects, a surgical implant structure is created for implantation in a human body, the implant comprising: a polyetheretherketone (PEEK) substrate; a titanium (Ti) layer a high power Impulse Magnetron Sputtering (HIPIMS) technique for generating a plurality of unipolar pulses formed on the outer surface of the polyetheretherketone substrate; and a titanium dioxide (TiO ₂ ) layer, Forming a plurality of unipolar pulses on the outer surface of the titanium layer by high-power pulsed magnetron sputtering; wherein the repetition frequency of each unipolar pulse ranges from 600 Hz to 1,000 Hz, pulse on time The range is between 100 μs and 200 μs, the pulse off time range is between 1,050 μs and 1,150 μs, and the average power range is between 5,000 W and 7,000 W.

In a preferred embodiment, the titanium layer has a total operating pulse time ranging from 15 minutes to 45 minutes.

In a preferred embodiment, the total operating pulse time of the titanium dioxide layer ranges from 1 hour to 3 hours.

In a preferred embodiment, each unipolar pulse comprises a plurality of micro pulses.

In a preferred embodiment, the pulse on time of each micropulse ranges from 100 μs to 200 μs, the pulse off time ranges from 1,050 μs to 1,150 μs, and the pulse period ranges from 1,000 μs to 1,667 μs. .

In a preferred embodiment, the implant can be a spinal fixator, a skull mesh, a bone anchor, or an artificial joint.

In a preferred embodiment, the polyetheretherketone substrate is a polyaryletherketone polymer substrate.

In a preferred embodiment, the polyaryletherketone polymer substrate is a polyetherketone, a polyetherketoneketone, a polyetherketoneetherketoneketone, or any combination thereof. Substrate.

In a preferred embodiment, the polyetheretherketone substrate is a fiber reinforced polyaryletherketone polymer substrate.

In a preferred embodiment, the fiber composite reinforced poly(aryl ether ketone) polymer substrate is a fiber reinforced polyetheretherketone, a fiber reinforced polyetherketone, and a fiber composite. A substrate reinforced with a reinforced polyetherketoneketone, a fiber reinforced polyetherketoneetherketone, or any combination thereof.

In order to achieve the above objectives and effects, the technical means and structure adopted by the present invention are described in detail in the preferred embodiment of the present creation, and the features and functions are as follows.

Please refer to FIG. 1a, which is a perspective view of a preferred embodiment of the surgical implant according to the present invention. As can be clearly seen from the figure, a surgical implant structure is created for implantation in a human body. The so-called "implant" can be a spinal fixator, a skull mesh, a bone anchor, or Artificial joints and the like can be implanted in the human body, but are not limited thereto. The implants made with high power pulsed magnetron sputtering technology have the advantage of high biocompatibility. Referring again to FIG. 1b, the implant comprises: a polyetheretherketone (PEEK) substrate 1, a titanium (Ti) layer 2, and a titanium dioxide (TiO ₂ ) layer 3.

The polyetheretherketone substrate 1 may be, for example, a polyaryletherketone polymer substrate or a fiber reinforced polyaryletherketone polymer substrate, but is not limited thereto. this. Wherein, the polyaryletherketone polymer substrate is a polyetherketone, a polyetherketoneketone, a polyetherketoneetherketoneketone, or a substrate of any combination of the above materials, but not Limited to this. The fiber composite reinforced poly(aryl ether ketone) polymer substrate is a fiber reinforced polyetheretherketone, a fiber reinforced polyetherketone, and a fiber reinforced polyetherketoneketone (Fiber reinforced polyetherketone). A polyetherketoneketone), a fiber reinforced polyetherketoneetherketoneketone, or a substrate of any combination of the above materials, but is not limited thereto.

The titanium layer 2 is formed on the outer surface of the polyetheretherketone substrate 1 by a high power pulsed magnetron sputtering technique to generate a plurality of unipolar pulses. Further, the term "formation" is used to deposit the titanium layer 2 on the outer surface of the polyetheretherketone substrate 1. Also, the total operating pulse time of the titanium layer 2 ranges from 15 minutes to 45 minutes.

The titanium dioxide layer 3 is formed on the outer surface of the titanium layer 2 by a high power pulsed magnetron sputtering technique to generate a plurality of unipolar pulses. Further, the so-called "formation" is to deposit the titanium dioxide layer 3 on the outer surface of the titanium layer 2. Also, the total operating pulse time of the titanium dioxide layer 3 ranges from 1 hour to 3 hours.

Wherein each of the high-power pulsed magnetron sputtering techniques generates a plurality of unipolar pulses, and the repetition frequency of each of the plurality of unipolar pulses ranges from 600 Hz to 1,000 Hz, and the pulse on time range is 100 μs. Between 200 μs, the pulse off time range is between 1,050 μs and 1,150 μs, and the average power range is between 5,000 W and 7,000 W. Each of the unipolar pulses can include a plurality of micro pulses. The micropulse is turned on for a time ranging from 100 μs to 200 μs, and the micropulse is turned off for a time ranging from 1,050 μs to 1,150 μs, and the period of the micropulse ranges from 1,000 μs to 1,667 μs.

Further, in order to verify that the structure of the present surgical implant is indeed a TiO ₂ /Ti layer stack structure on the surface of the polyetheretherketone substrate 1, please also refer to FIG. 2, which is based on the present surgical implant. A scanning electron microscope (SEM) photograph of a preferred embodiment of the substrate structure. As is clear from the figure, the titanium layer 2 deposited by the high-power pulsed magnetron sputtering technique can be closely attached to the surface of the polyetheretherketone substrate 1; subsequently deposited by high-power pulsed magnetron sputtering technology. The titanium dioxide layer 3 can also be closely attached to the titanium layer 2. The thickness of the titanium layer 2 and the titanium dioxide layer 3 is not particularly limited and may be adjusted by the process time.

In order to verify that the surface laminate structure of the present surgical implant is indeed the surface of the titanium layer 2 and the titanium dioxide layer 3 on the polyetheretherketone substrate 1. Please also refer to FIGS. 3a and 3b, which are X-ray diffraction patterns and Raman spectra of the crystal structure of the surgical implant structure according to the present invention. It can be seen from the X-ray diffraction pattern shown in FIG. 3a that the Ti (010), Ti (002), Ti (011) and Ti (012) signals of the titanium layer 2 and the R-TiO _{2 of the} titanium dioxide layer 3 can be detected. (110) Signal. Next, the Raman spectrum of Fig. 3b was again examined for the titanium dioxide layer 3, which was confirmed to be rutile phase titanium dioxide (Rutile Phase-TiO ₂ ; R-TiO ₂ ).

To verify that the surgical implant structure does have good biocompatibility, this work performed a biocompatibility test on the TiO ₂ /Ti/PEEK layer stack structure and performed it with a pure polyetheretherketone substrate. Comparison. Referring to Figures 4a and 4b, these are the Osteoblast attachment state diagrams and the osteoblast proliferation test for testing the biosynthesis test of the surgical implant structure and the pure polyetheretherketone substrate. Figure. The results show that the surgical implant structure can provide an excellent growth environment for the osteoblasts, so the osteoblast can be completely applied to the surface of the titanium dioxide layer, and the cell proliferation test also has better performance. In summary, this creation does have good biocompatibility.

With the above structure and composition design, the following is the use of this creation: The creation uses high-power pulsed magnetron sputtering technology for coating, and has good adhesion, defect-free (Defect-free), super Excellent properties such as compactness, good winding properties, good coverage for complex substrates, and relatively low temperature growth crystal structure. The creation of the titanium dioxide layer / titanium layer / polyether ether ketone substrate sandwich structure as a surgical implant, can achieve good biocompatibility.

Therefore, please refer to all the drawings. When using this design, compared with the conventional technology, the following advantages exist: the surgical implant structure is manufactured by high-power pulsed magnetron sputtering technology, and has a height. The advantage of biocompatibility.

However, the above description is only for the preferred embodiment of the present invention, and thus the scope of the patent is not limited thereby, so the simple modification and equivalent structural changes of the present specification and the drawings are the same. It is included in the scope of this patent and is given to Chen Ming.

1‧‧‧Polyetheretherketone substrate
2‧‧‧Titanium layer
3‧‧‧ Titanium dioxide layer

[Fig. 1a] is a perspective view of a preferred embodiment of a surgical implant structure in accordance with the present invention. [Fig. 1b] is a cross-sectional view taken along line AA of Fig. 1a in accordance with a preferred embodiment of the present surgical implant structure. [Fig. 2] is a scanning electron microscope (SEM) photograph of a preferred embodiment of the surgical implant structure according to the present invention. [Fig. 3a] is an X-ray diffraction pattern of the crystal structure of the surgical implant according to the present invention. [Fig. 3b] is a Raman spectrum of the crystal structure of the surgical implant according to the present invention. [Fig. 4a] is a state diagram of the Osteoblast attachment test for testing the structure of the surgical implant and the pure polyetheretherketone substrate in the biocompatibility test. [Fig. 4b] is a test for the osteoblast proliferation test of the biosynthesis test of the present surgical implant structure and the pure polyetheretherketone substrate.

1‧‧‧Polyetheretherketone substrate

2‧‧‧Titanium layer

3‧‧‧ Titanium dioxide layer

Claims (10)

A surgical implant structure for implantation in a human body, the implant comprising: a polyetheretherketone (PEEK) substrate; a titanium (Ti) layer, which is pulsed with high power pulsed magnetron High Power Impulse Magnetron Sputtering (HIPIMS) produces a complex unipolar pulse formed on the outer surface of the polyetheretherketone substrate; and a titanium dioxide (TiO ₂ ) layer with high power pulsed magnetron sputtering The technique generates a plurality of unipolar pulses formed on the outer surface of the titanium layer; wherein the repetition frequency of each unipolar pulse ranges from 600 Hz to 1,000 Hz, and the pulse on time ranges from 100 μs to 200 μs, and the pulse The pulse off time range is from 1,050 μs to 1,150 μs and the average power range is between 5,000 W and 7,000 W. The surgical implant structure of claim 1 wherein the total operating pulse time of the titanium layer ranges from 15 minutes to 45 minutes. The surgical implant structure of claim 2, wherein the total operating pulse time of the titanium dioxide layer ranges from 1 hour to 3 hours. The surgical implant structure of claim 1, wherein the unipolar pulses comprise a plurality of micro pulses. The surgical implant structure as described in claim 4, wherein the pulse on time of each micropulse ranges from 100 μs to 200 μs, and the pulse off time ranges from 1,050 μs to 1,150 μs, pulse The period ranges from 1,000 μs to 1,667 μs. The surgical implant structure as described in claim 1, wherein the implant is a spinal fixator, a skull mesh, a bone anchor, or an artificial joint. The surgical implant structure according to claim 1, wherein the polyetheretherketone substrate is a polyaryletherketone polymer substrate. The surgical implant structure according to claim 7, wherein the polyaryletherketone polymer substrate is a polyetherketone, a polyetherketoneketone, a polyetherketone ether ketone. A substrate of a ketone (Polyetherketoneetherketoneketone) or any combination thereof. The surgical implant structure according to claim 1, wherein the polyetheretherketone substrate is a fiber reinforced polyaryletherketone polymer substrate. The surgical implant structure according to claim 9 , wherein the fiber composite reinforced poly(aryl ether ketone) polymer substrate is a fiber reinforced polyetheretherketone or a fiber composite reinforced polypolymer. A substrate of a fiber reinforced polyetherketone, a fiber reinforced polyetherketoneketone, a fiber reinforced polyetherketoneetherketone, or any combination thereof.